Specialty Pharmacy - National Home Infusion Association · 2020. 4. 21. · ment System. Multiple benefits to using indi-cation-based formularies exist. Plan sponsors will have the

NHIA, Others Call for Changes to Proposed Home Infusion RuleAlthough legislation signed earlier this year established a transitional payment

to plug a reimbursement gap for home infusion therapy, a proposed rule is threat-ening both the temporary and permanent reimbursement for this service. The Na-tional Home Infusion Association (NHIA) and other stakeholders are calling for the administration to modify the final rule in order for it to align with the legislation.

Specifically, NHIA is calling for the removal of language requiring the physical presence of a nurse when a drug is administered to a patient and for there to be a specific definition of the professional services that are associated with home infusion.

Traditionally Medicare reimbursed for home infusion drugs but not the profes-sional services associated with the infusions themselves. This changed in December 2016 with the signing of the 21st Century Cures Act, which established a reim-bursement structure for the professional services that are provided with home infu-sion therapies (RSP 2/18, p. 1). However, this does not take effect until Jan. 1, 2021.

The act also changed the reimbursement methodology for Part B infusible drugs furnished through durable medical equipment (DME). The Medicare Mod-ernization Act established an average sales price (ASP)-based methodology for most Part B drugs. However, it excluded Part B infusible drugs furnished through DME — such as chemotherapy administered with an infusion pump — from shifting to ASP, instead basing these therapies’ reimbursement on October 2003 average whole-sale prices (AWPs). The law went into effect Jan. 1, 2005 (RSP 10/04, p. 7), and reimbursement for these therapies continued to be based on those same AWPs.

continued on p. 10

September 2018VOLUME 15 | NUMBER 09

4 CVS Will Exclude Certain Drugs Based on ICER Analyses of QALY

5 Drug Price Increases Are Expected to Slow, but Specialty Prices Continue to Dominate Spending

7 Express Scripts Will Exclude Some HAE, HIV, Factor Products

8 New FDA Specialty Approvals

12 News Briefs

Indication-Based Formularies in Part D Offer Benefits and RisksThe administration continues to take steps that it hopes will bring down drug

prices. In the latest move, CMS Administrator Seema Verma said in an Aug. 29 memo to Medicare Part D plan sponsors that they can begin using indication-based formularies in contract year 2020. Industry experts tell AIS Health that the decision definitely has benefits, including giving plans the ability to negotiate higher dis-counts and providing biosimilars an advantage. On the flip side, potential risks are inherent in the approach, including challenges with operationalizing the policy and the evidence needed to prefer one product over another.

Currently, plan sponsors can use prior authorization (PA) to apply varying ap-proval criteria — a certain diagnosis or result of a diagnostic test, for example — for specific indications. In addition, plans must cover any drug on a formulary for all the indications for which it has FDA approval except for those drugs excluded from Part D based on statutory and regulatory requirements. But starting in 2020, “Part D sponsors may utilize step therapy-like requirements within their PA to promote cost-effective drug therapy by requiring the use of one formulary drug for a certain

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indication prior to authorizing cover-age of a second drug for that indica-tion,” explains the memo, which notes that some commercial health plans already use this approach.

The memo makes clear that a plan taking an indication-based approach “must ensure that there is another ther-apeutically similar drug on formulary for the non-formulary indication,” or CMS may decide that it is not adher-ing to the anti-discrimination require-ments outlined in the Social Security Act. All other Medicare formulary requirements apply, including coverage of drugs within protected classes.

“If a Part D sponsor excludes spe-cific indications for a Part D drug from its formulary, requests for coverage for those excluded indications should be treated as an exception request for an off-formulary drug,” says the memo. Plans that take this approach must update their beneficiary materials for 2020 to make sure prospective enroll-

ees are aware of the policy. Plans also must submit the indication informa-tion to CMS’s Health Plan Manage-ment System.

Multiple benefits to using indi-cation-based formularies exist. Plan sponsors will have the “ability to nego-tiate steeper discounts in the specialty space — not tied into a single rate for utilization of a product across multiple indications,” says Andrew Cournoyer, R.Ph., vice president, director – payer access solutions at Precision for Value. “For example, a drug may have strong utilization in one indication, driving meaningful rebate revenue, but weaker utilization in another indication. Pay-ers won’t be handcuffed based upon performance in a single indication and can maximize rebate potential across multiple indications.”

Plans will be able “to assign a combination of higher payment and/or lower cost share for a treatment used for a particular indication, where

evidence shows that this treatment for that indication is likely to yield a better outcome compared to alterna-tive treatments,” says Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates. In addition, for uses of a drug in which evidence offers worse outcomes compared with alternatives, plans can “assign a lower payment and/or a higher cost share.”

Firms Need New Contracting Strategies

“Drug manufacturers will need to alter their contracting strategies to match their competition in various seg-ments,” says Cournoyer, as “preferred access across the board will be harder to achieve, and, as a result, discounts may increase.”

In addition, he tells AIS Health, “Manufacturers of biosimilars may also gain advantage. Aggressive WAC [i.e., wholesale acquisition cost] pricing coupled with a contracting approach may provide net cost benefits to the payer across a number of indications, or a biosimilar could be more aggres-sive in one indication over another to gain initial market entry. Either scenar-io could result in favorable access for a biosimilar entrant.”

While the Medicaid best price rule may be an impediment to value-based pricing in commercial markets, prices for drugs covered by Part D don’t trig-ger that rule, points out Rubinstein, so discounts for these products don’t impact Medicaid pricing.

The policy, however, has multiple potential downsides and risks. Cour-noyer points out that it won’t impact the broader population: “The benefit enhancement is simply a catch-up play for the Medicare population, which represents only about 15% of the population. Moreover, its impact is most likely targeted at specialty drugs, which are utilized by approximately

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Managing Editor, Angela Maas; Executive Editor, Jill Brown; Director, Data Solutions, Susan Namovicz-Peat

EDITORIAL ADVISORY BOARD: Al Heaton, Pharm.D., Director of Pharmacy Management, UCare, Chris Nee, Pharm.D., President, PharMedQuest, Lee Newcomer, M.D., Senior Vice President of Oncology Services, UnitedHealthcare, Bill Noyes, Vice President, Health Information Policy, National Home Infusion Association, Nicholas Opalich, President and Chief Operating Officer, Western Operations, ProCare Rx, Elan Rubinstein, Pharm.D., Principal, EB Rubinstein Associates, Rebecca Shanahan, CEO, Avella Specialty Pharmacy, Debbie Stern, Senior Vice President of Strategy and Business Development, CareCore National, William Sullivan, Principal Consultant, Specialty Pharmacy Solutions, LLC, David Willcutts, President and General Manager, Integrated Home Care, Univita Health

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2% to 3% of the population. So, when combining these numbers, the overall impact to the insured population is quite low.”

Beneficiaries, he says, “will likely not ‘feel’ the impact from an afford-ability perspective. The goal of the initiative is to enhance the negotiat-ing leverage of payers, which in turn should increase the rebate stream. Without any pass-through of rebates to the member” — which a handful of payers have said they will begin apply-ing at the point of sale (RSP 6/18, p. 1) — “the benefit to the member is really only felt in premium expenditures, which are relatively flat year over year.”

What Is Sufficient Evidence to Prefer?

Rubinstein questions “what con-stitutes sufficient evidence to support preference for one product over an-other as a matter of policy and benefit design, if there are patient-specific variables such as severity, age, mobility, comorbidities or other matters that should be taken into consideration?” For this reason, he wonders what the role of real-world data will be in this decision making. “Aside from clinical benefit for a particular indication, how will differences in adverse event frequency and severity reflect in the plan's preference decision, particularly if adverse event importance varies with patient-specific factors such as age, comorbidity and condition?”

“If Part D plans evaluate the same evidence and come to a different conclusion, will that decision process be transparent and defensible to pre-scribers who may treat patients from different Part D plans and who might not agree with one or the other of the Part D plan interpretations of the evidence?” asks Rubinstein. He tells AIS Health that “it's easier to defend step-therapy preference of therapeuti-

cally similar products A vs. B in a drug formulary due to a favorable contract with a manufacturer, but a more diffi-cult challenge to defend diametrically opposed interpretations of published evidence with respect to products A vs B. So will indication-based formulary decisions only apply where the evi-dence is strong, reflect the evidence in a defensible and transparent manner, and always yield the same preference?”

With prescriptions not needing to show an indication for a drug and systems for PBMs and specialty, com-munity and mail-order pharmacies not recording the indication “if [it’s] not part of a prior-authorization protocol that specifically requires it,” Rubinstein questions how this policy will be oper-ationalized.

Will It Affect Pharmacies’ Gross Margins?

“If the indication for which a prescription is dispensed is reflected in reimbursement to the pharmacy, and given that the pharmacy purchased the inventory at a particular price from the wholesaler, will dispensing a drug for a non-preferred indication impact the dispensing pharmacy gross margin — and if yes, how does phar-macy financial risk reflect its ability to influence the indication for which the drug is prescribed?” asks Rubinstein. “That is, might the dispensing phar-macy be penalized for something that is confusing (e.g., on the basis of the same evidence, plan A prefers product #1, while plan B prefers product #2 for a given indication), does not have sufficient transparency to explain to the patient, sufficient clinical or pa-tient-specific condition information to judge if/whether to try to influence the prescriber's decision vs. call the plan to seek an exception, nor sufficient information to audit that it was paid appropriately by the PBM?”

Another challenge will be how payers can “verify the correctness of a drug written for a preferred indica-tion,” Rubinstein says. “Can indica-tion-based pricing be gamed?”

In addition, he says, if manu-facturers vary purchase prices and discounts for products based on their formulary position, “how will that be implemented, and what's to stop pur-chasing for preferred indication A, but administering/dispensing for non-pre-ferred indication B?”

Policy Could Encourage Rebate ‘Games’

According to an Aug. 29 research note from Evercore ISI analysts Ross Muken and Michael Newshel, indica-tion-based formularies “make sense and should give PBMs some incremental negotiating leverage by multiplying their options for building formular-ies. But at the same time this could encourage more of the rebate ‘games’ described by HHS where manufactur-ers raise list price and rebate dollars to get onto formularies, highlighting the tension between the administration’s consideration of restricting rebates and its desire to broaden the negotiating leverage of PBMs,” including the new policy change allowing Medicare Ad-vantage plans to apply step therapy to Part B drugs (RSP 8/18, p. 4).

As far as drug classes likely to be affected by the policy, specialty drugs “are the most likely targets on the basis of high cost per prescription, high year-over-year trend of specialty relative to non-specialty pharmaceuticals…and the prediction that specialty will soon comprise half of drug benefit spend,” says Rubinstein. Cournoyer agrees that these drugs are likely targets due to their high prices and “multiple indica-tions with varied competition in each indication.”

September 2018 Radar on Specialty Pharmacy 3

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Within the specialty medications, the anti-inflammatory products used in conditions such as rheumatoid ar-thritis, psoriasis and Crohn’s are likely, with Verma even mentioning the tu-mor necrosis factor (TNF) inhibitors in her memo. This is a class with nu-merous high-cost therapies, and some payers, including CVS Health, have launched indication-based formularies for it. Hepatitis C drugs, expensive therapies that are approved for differ-ent genomes of the virus, also could be contenders.

Grandfathering Is Likely for Most Plans

Both Cournoyer and Rubinstein believe that plans will grandfather in those beneficiaries who are on a drug for an indication that’s not on formu-lary. “I envision that most plans will grandfather patients,” says Cournoyer. “Disrupting existing care, especially treatment that has been effective, is generally frowned upon by CMS. Furthermore, patient disruption on this front could result in Medicare complaints, which can adversely affect star ratings. Transition policies will also continue to take effect, and plans will need to provide ample notice to bene-ficiaries if they opt not to grandfather patients (which opens the door for CMS auditing opportunities).”

Patients who already are on a drug for an indication in which it is pre-ferred “will also enjoy the lower cost-share (relative to what they were paying out of pocket before the change) or whatever other benefits are bestowed for use of a preferred product for a preferred indication,” points out Ru-binstein.

So what should drug manufactur-ers do to make sure their drugs receive favorable formulary positions? For one, Rubinstein tells AIS Health, they will need to “ramp up demonstration of ef-

ficacy and value via real world data/‘big data’ analysis.”

“Payers will be in a position to redefine market baskets,” says Cour-noyer. “No longer will TNF inhibitors be a market basket across an indication set but rather a market basket with-in an indication subset. As a result, manufacturers will need to look at their value propositions (clinical and financial) within an indication and across indications. Bid proposals will need to look at total value and have the added flexibility of varying contract-ing rates across different indications (as opposed to one flat rate). There is also an opportunity to expand value or outcomes-based contract opportunities to look at holistic drug performance across all utilizing populations. For example, will a manufacturer hedge its drug’s performance across an indication-agnostic measure such as adherence or persistence, and does this arrangement give a competitive edge?”

View the CMS memo at https://tinyurl.com/y86fbpuc. Contact Cour-noyer through Tess Rollano at [email protected] and Rubinstein at [email protected]. G

CVS Will Exclude Certain Drugs Based on ICER Analyses of QALY

At the time of year when PBMs are rolling out their 2019 strategies, CVS Health has unveiled a bold new approach to managing certain specialty drugs based on data from the Institute for Clinical and Economic Review (ICER). However, industry experts are divided on how much of an impact it truly will have on drug prices.

In a white paper out last month, titled Current and New Approaches to Making Drugs More Affordable, CVS revealed that it’s starting a program fo-

cused on bringing down launch prices of pricey me-too drugs. The approach allows clients to exclude those med-ications that come onto the market with a price more than $100,000 per quality-adjusted life year (QALY) as determined by publicly available ICER analyses. Drugs to which the FDA has given breakthrough therapy status will not be eligible for exclusion.

Program Focuses on Costly Me-Too Drugs

By focusing on “expensive, ‘me-too’ medications that are not cost effective,” the approach, contends the white paper, will help “put pressure on manufacturers to reduce launch prices to a reasonable level.” Noting that drugmakers are the only stakeholder with the ability to control launch pric-es, the PBM maintains that “this new approach, harnessing the power of the market, could change manufacturer behavior. CVS Caremark continues to use other PBM techniques to help lower costs for payors and their mem-bers, but lower launch prices could help bring about real deflation in drug prices.”

CVS spokesperson Christine Cramer confirms that the company is beginning to roll out the program now, which is “focused on new drugs enter-ing the market moving forward.” She notes that the PBM has not announced which drugs would be excluded under the program.

The white paper includes a chart that shows high launch prices for cer-tain drugs starting in 1997 with Teva Neuroscience, Inc.’s Copaxone (glati-ramer acetate). Interestingly, of the sev-en drugs included in the graphic that were first approved starting in 2013 — the breakthrough therapy designation, which was created as part of the Food and Drug Administration Safety and Innovation Act, was unveiled July 9,


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2012, when FDASIA was signed into law — six had breakthrough therapy designation, so they would have been ineligible for the CVS program.

CVS’s approach is “another exam-ple of how payers and PBMs are look-ing at opportunities to manage drug

costs by tying access to competitive

cost-effectiveness,” according to Ami

Gopalan, Pharm.D., vice president,

director, payer access solutions at Pre-

cision for Value. “As therapeutic classes

become more competitive, encom-

passing multiple products with similar

efficacy and safety, programs like the one promoted by CVS provide another option for formulary management.”

The program is “a credible ap-proach to better managing drug spend for its clients,” maintains Elan Ru-binstein, Pharm.D., principal at EB

Drug Prices Increases Are Expected to Slow, but Specialty Prices Continue to Dominate Spending

Pharmaceuticals are expected to undergo a 4.92% price increase from 2018 to 2019, according to the recently released July-August 2018 Drug Price Forecast from Vi-zient. That’s actually a slowing from the 7.61% increase for 2018. The company conducted its analysis using price and volume data from hospital and non-acute facilities par-ticipating in its Vizient Pharmacy Program. Among Vizient members, therapeutic classes with the highest spend include many with specialty drugs (see table below).

Disease-modifying antirheu-matic agents lead the way with an estimated 8.57% increase, followed by the immunomodulatory agents for multiple sclerosis, at 7.33%. Ac-cording to the report, “Based on the total amount of spend across care environments, the types of molec-ular entities approved by the FDA, and the investigational products in the development pipeline, it is cer-tain that specialty pharmaceuticals will continue to play an increasingly important role in pharmacy budget-ing.” However, a handful of events

have occurred that are helping slow drug price increases, including CMS giving biosimilars a unique reim-bursement code and pass-through status, as well as the administration’s initiative to bring down drug prices.

Challenges within the system include the fragility of the pharma-ceutical supply chain, which is lead-ing to multiple drug shortages, and novel new medications that launch at very high prices.

Download the report at https://tinyurl.com/ycbfcjmg.



Rubinstein Associates. “This approach strengthens PBMs’ business case for how PBMs add value, which has come under increasing fire from all sides and which may be under even more pres-sure if the safe harbor which protects manufacturer class of trade discounts and rebates is eliminated” (RSP 6/18, p. 1).

Approach Needs Careful Evaluation

Other reactions were more skepti-cal. “Already ‘me-too’ drugs are subject to negotiation such that they can be excluded from formularies — I’m not sure if this is going to have such a material effect on them,” says Lisa Kennedy, Ph.D., chief economist at Epiphany, a company that performs health economics, reimbursement and market access studies. “The question is how this will affect innovative drugs where there are fewer alternatives for patients. Any decision to use this ap-proach needs to also be carefully eval-uated in the context of how it could help or harm patients, which I’m sure CVS will do.…I can’t see a lot of bene-fits to this approach.”

In response to the program, “man-ufacturers may increase the weight of value criteria to assess candidate viability and inform pipeline culling considerations during the R&D pro-cess,” Rubinstein tells AIS Health. “Self-insured employers may face pushback from employees and depen-dents who are denied access to me-too products excluded from coverage on the basis of value below threshold. HR departments will need to find ways to communicate about rationale and justification for this.”

According to Gopalan, “One point to keep in mind is there can be different interpretations of what is considered a me-too medication. In addition, a QALY pricing threshold of

$100,000 may not be appropriate for all scenarios.”

Cramer did not respond to a question about why CVS chose drugs exceeding $100,000 per QALY as opposed to another amount, such as $50,000 or $150,000 per QALY.

According to Kennedy, QALYs are “as complicated as the concept sounds. The purpose of using the QALY is to be able to compare all innovations with a common unit of benefit. The problem is that QALYs are hard to understand and exhibit extraordinary methodological and practical problems: They aren’t reliable across the same patients over time, across different patients and, additionally, fall down when required to measure more diffi-cult things such as QALYs in the elder-ly or the very young. QALYs are often mapped from quality-of-life measures collected in a trial. What can happen is that the quality-of-life instruments used are not sensitive enough to cap-ture meaningful change for the pa-tient.”

Move Is Step in Right Direction for U.S.

Yet although “one might argue with the methodology” used to assess value, Rubinstein tells AIS Health, “the fact of the matter is that this is a step in the right direction for the United States, where pursuing value is something of a new thing that has had difficulty getting established — and in light of a health care cost trend which regularly exceeds CPI-U [i.e., Con-sumer Price Index for All Urban Con-sumers], and which likely holds down wage increases since employers look at the whole 'package' of employee costs. When other package costs rise faster, then wages have less room to rise.”

“I’m not sure how this will affect products at launch, but it could func-tion to put pressure on manufacturers

not to raise their prices over time — this combined with competitive pres-sure,” Kennedy tells AIS Health.

Lower Net Prices May Be Outcome

“While it may not hold down list prices of me-too products, CVS's move may result in lower net prices for PBMs and insurers that go this route, as manufacturers negotiate to avoid flat-out exclusion from a drug formu-lary,” Rubinstein states. “Me-too prod-ucts with similar efficacy and safety as ones already on the market will face a higher bar to launch than they have in the past, if PBMs and insurers follow CVS's lead in using a QALY threshold for product formulary listing vs ex-clusion. That will mean deeper price concessions but not necessarily com-mensurately lower launch prices.”

“Manufacturers will need to evalu-ate their launch pricing scenarios close-ly to understand the potential impact of a program offering like CVS’s,” Gopalan says. “For manufacturers entering highly competitive categories, alternative pricing strategies will need to be considered.”

In order for drugmakers to successfully launch their products, “beyond safety and efficacy, manu-facturers need to plan to demonstrate the clinical and economic value their product brings to the marketplace,” she maintains.

“Generating evidence that sup-ports the value of their product will be important to be successful.”

View the CVS white paper at https://tinyurl.com/ybgm4n8n. Con-tact Cramer at [email protected], Gopalan through Tess Rollano at [email protected], Kennedy at [email protected] and Rubinstein at [email protected]. G



Express Scripts Will Exclude Some HAE, HIV, Factor Products

With 48 new exclusions on its 2019 National Preferred Formulary (NPF), Express Scripts Holding Co. is getting more aggressive in its attempt to broaden access to pharmaceuticals and bring value to its clients. But some industry stakeholders are questioning its strategy of excluding more specialty drugs, including some for rare condi-tions, as well as a low-cost pangenomic hepatitis C medication.

The new exclusions are on top of the 196 drugs Express Scripts already is excluding in 2018. In 2019, the NPF will cover more than 25 million lives and will include 3,886 medications. The PBM estimates that it will save $3.2 billion. Those plans that have continuously used the NPF since Ex-press Scripts introduced it in 2014 will save $10.6 billion total through next year, projects the company.

Among the new exclusions are the following:

✦✦ Novartis Pharmaceuticals Corp.’s multiple sclerosis drug Extavia (inter-feron beta-1b);

✦✦ Four factor VIII recombinant products for hemophilia: Eloctate from Bioverativ, a Sanofi company; Shire US Inc.’s Recombinate; and Pfiz-er Inc.’s Xyntha and Xyntha Solofuse;

✦✦ AbbVie Inc.’s hepatitis C medica-tion Mavyret (glecaprevir/pibrentas-vir);

✦✦ CSL Behring LLC’s Berinert (C1 esterase inhibitor, human), indicated for the treatment of acute abdominal, facial or laryngeal hereditary angioede-ma (HAE) attacks in adult and pediat-ric patients; and

✦✦ Gilead Sciences, Inc.’s HIV drug Atripla (efavirenz/emtricitabine/teno-fovir disoproxil fumarate).

Express Scripts has a formulary exception process by which patients who cannot use a preferred therapy can seek an exception.

Jennifer Luddy, a spokesperson for Express Scripts, tells AIS Health that “no formulary decision is based strictly on price. First, our independent P&T [i.e., pharmacy & therapeutics] com-mittee reviews medications and makes recommendations based on clinical evi-dence. Medications they deem ‘manda-tory include’ are included. Medications which are a ‘may add’ have therapeutic alternatives available, and then we can make a decision based on price.”

“After clinical considerations, for-mulary preference is given to high-val-ue therapies with the lowest net cost, achieved through low list price, rebate, or both,” says Express Scripts.

Some Exclusions Were Surprising

According to Jeremy Schafer, senior vice president at Precision for Value, “The inclusion of categories like HIV, hereditary angioedema and he-mophilia was certainly a surprise. Rare disease categories such as these were commonly seen as too sensitive and individualized to be managed by some-thing as blunt as an exclusion. Even though Express Scripts is grandfather-ing current users, this move represents an aggressive step in the management of rare disease drugs.”

But with multiple therapies in hemophilia, HIV and HAE, why shouldn’t PBMs exclude some of them?

Schafer tells AIS Health that “a primary reason may be that patient care in these diseases is so individu-alized. The diseases included here are very nuanced, and patient presentation is highly variable. For categories like HAE and hemophilia, product supply, site of care and variances in dose play additional roles. As a result, different

drugs often have carved out niches in unique subpopulations. An exclusion doesn’t take into account these nuances and instead blocks out affected prod-ucts. Although appeals for coverage may be made, it is a blunt instrument in drug management.”

Within the HAE space, says Lud-dy, “we leveraged increased competi-tion in that class to maintain access to a variety of therapies (there are eight preferred alternatives in that class) at a lower cost.”

However, “some patients respond better to certain products, so physi-cians might experiment with one or more products to see which ones are most effective in managing the disease and symptoms,” Elizabeth Duruz, R.Ph., director of clinical program services at Diplomat Specialty Infusion Group, a brand of Diplomat Pharmacy Inc., tells AIS Health (RSP 3/18, p. 1). For example, some patients may think that one HAE product works really well for facial attacks, but another works better for abdominal attacks.

PBM Will Exclude Four Hepatitis C Drugs

Within the hepatitis C class, in addition to Mavyret, the PBM also will continue to exclude Bristol-Myers Squibb Co.’s Daklinza (daclatasvir), Janssen Therapeutics’ Olysio (sime-previr) — which Janssen discontinued earlier this year — and Gilead’s Sovaldi (sofosbuvir). On the 2019 NPF are Gilead’s Epclusa (sofosbuvir/velpat-asvir), Harvoni (ledipasvir/sofosbuvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) and Merck & Co., Inc.’s Zepatier (elbasvir/grazoprevir), which currently is excluded.

“We have successfully driven down the cost to cure hepatitis C over the last four years, and once again we’re taking action to further lower client costs,” says Luddy. “In July 2018, Mer-



ck announced a 60% price reduction for Zepatier that will take place in the fourth quarter of 2018. That will make Zepatier the lowest-cost agent for a 12-week course of therapy. Because of this market dynamic shift, Zepat-ier will be added to formulary effec-tive Jan. 1, 2019. At the same time, Mavyret will be excluded on the NPF. All current utilizers of Mavyret will be grandfathered to allow completion of

their treatment course. For 2019, the Express Scripts NPF will have a combi-nation of the market leading products (Harvoni and Epclusa) and the low-cost leader (Zepatier) on the formulary, as well as Vosevi.”

Adam Fein, Ph.D., author of the Drug Channels blog and CEO of Drug Channels Institute, noted in an Aug. 16 blog that excluding Mavyret is a “patient unfriendly change to the hep-

atitis C category.” That’s because while that therapy is indicated for genotypes 1 through 6 — as is Epclusa — Zepati-er is indicated for only genotypes 1 and 4. Harvoni is indicated for genotypes 1, 4, 5 and 6.

As he wrote in his blog, “Until recently, Mavyret had the lowest list price. AbbVie launched Mavyret in

continued on p. 10

New FDA Specialty Approvals

✦✦ Aug. 15: The FDA expanded the approval for Kalydeco (ivacaftor) to include the treatment of chil-dren with cystic fibrosis at least 12 months old who have at least one mutation in their cystic fibrosis transmembrane conductance regula-tor (CFTR) gene that is responsive to Kalydeco based on clinical and/or in vitro assay data. The agency first approved the Vertex Pharmaceuticals Inc. drug in January 2012 (RSP 2/12, p. 8). Dosing is age- and weight-based. The product is available as a 150 mg tablet and oral granules. Website GoodRx lists the price of one carton containing 56 150 mg tablets as more than $23,700. Visit www.kalydeco.com.

✦✦Aug. 16: The FDA granted an ad-ditional approval to Lenvima (len-vatinib) for the first-line treatment of people with unresectable hepatocel-lular carcinoma (HCC). The agency initially approved the capsule from Eisai Inc. and Merck & Co., Inc. for the treatment of differentiated thyroid cancer in 2015 (RSP 3/15, p. 11); it’s also approved for renal cell carcinoma (RSP 6/16, p. 6). Dosing for the newest indication is 12 mg once daily for people weighing at

least 60 kg and 8 mg once daily for people less than 60 kg. According to Reuters, Eisai will price the recom-mended starting dose for HCC at $15,970 for a 30-day supply. Visit www.lenvima.com.

✦✦Aug. 17: The FDA gave accelerated approval to Opdivo (nivolumab) for the treatment of people with metastatic small cell lung cancer whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. The FDA first approved the Bris-tol-Myers Squibb Co. programmed death receptor-1 (PD-1) inhibitor in December 2014 for the treatment of unresectable or metastatic melanoma (RSP 1/15, p. 6). Dosing for the new-est indication is 240 mg as a 30-min-ute intravenous infusion every two weeks. GoodRx lists the price of one 100 mg/10 mL vial as more than $2,600. Visit www.opdivo.com.

✦✦Aug. 17: The FDA gave an ad-ditional indication to Eylea (af-libercept) for the treatment of wet age-related macular degeneration on a 12-week dosing schedule. The Re-generon Pharmaceuticals, Inc. intrav-itreal injection already was approved

for use every four weeks and every eight weeks after three initial month-ly doses. The FDA initially approved the drug in November 2011 (RSP 12/11, p. 8). Website Drugs.com lists Eylea’s price as more than $1,900. Visit www.eylea.com.

✦✦Aug. 20: The FDA expanded the label of Keytruda (pembrolizumab) to include its use in combination with Alimta (pemetrexed) and plati-num chemotherapy for the first-line treatment of people with metastatic nonsquamous non-small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or ALK genomic tumor aberrations. The agency initially gave the Merck PD-1 inhibitor in combination with Alimta and carboplatin accelerated approval in 2017 (RSP 6/17, p. 6). Dosing is 200 mg of the intravenous infusion every three weeks. GoodRx lists the price of three 50 mg vials as more than $6,700. Visit www.key-truda.com.

✦✦Aug. 21: The FDA expanded the use of the Dako PD-L1 IHC 22C3 pharmDx assay to identify people with urothelial carcinoma who may benefit from Keytruda. The agency



has approved the Agilent Technolo-gies Inc. companion diagnostic for use in multiple other cancers. Visit https://tinyurl.com/ybmruoyo.

✦✦Aug. 22: The FDA approved Dompé farmaceutici S.p.A.’s Oxervate (cenegermin-bkbj) for the treatment of neurotrophic keratitis in people at least two years old. The agency gave the recombinant human nerve growth factor priority review and fast track status, as well as break-through therapy and orphan drug designations. The company says it will launch the ophthalmic solution in the U.S. by early 2019. Dosing is six times per day for eight weeks. Visit https://tinyurl.com/ya86gayo.

✦✦Aug. 23: The FDA approved Bioco-dex SAS’s Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome in people at least two years old who are taking clobazam. The agency gave the prod-uct orphan drug designation. It is available in two formulations: cap-sules and powder for oral suspension. The company says it expects the drug to be available in early January 2019. Visit www.biocodex.com/en.

✦✦Aug. 23: The FDA gave another indication to the cobas EGFR Mutation Test v2 as a companion diagnostic for AstraZeneca’s Iressa (gefitinib) in people with NSCLC. The FDA has approved the Roche Diagnostics test as a companion di-agnostic for other drugs to determine NSCLC EGFR mutation status. Visit www.cobasegfrtest.com.

✦✦Aug. 23: The FDA approved Shire plc’s Takhzyro (lanadelumab-flyo)

for prophylaxis to prevent hereditary angioedema attacks in people at least 12 years old. The plasma kallikrein inhibitor is the first monoclonal antibody the agency has approved for this indication. The drug, which can be self-administered, had break-through therapy and orphan drug designations, as well as priority review. The recommended starting dose for the subcutaneous injection is 300 mg every two weeks, which may shift to every four weeks if the patient is well controlled for more than six months. Visit www.takhzy-ro.com.

✦✦Aug. 27: The FDA expanded the indication for Imbruvica (ibruti-nib) in combination with Rituxan (rituximab) to treat adults with Waldenström's macroglobulinemia (WM). This approval makes the drug, which is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Inc. company, and Janssen Biotech, Inc., the first and only chemotherapy-free combina-tion treatment for the disease. The Bruton’s tyrosine kinase inhibitor came onto the U.S. market after the agency gave it accelerated approval in 2013 for the treatment of mantle cell lymphoma (RSP 12/13, p. 7); it now has approval for multiple in-dications. It is available in capsule and tablet formulations. Dosing for WM is 420 mg once daily. GoodRx lists the price of 90 140 mg capsules as more than $12,100. Visit www.imbruvica.com.

✦✦Aug. 30: The FDA approved Bayer Corp.’s Jivi (antihemophilic factor [recombinant] PEGylated-aucl) for

the prophylactic treatment of he-mophilia A, as well as on-demand treatment and perioperative manage-ment, in previously treated people at least 12 years old. The initial recommended dosing regimen for prophylaxis is 30-40 IU/kg twice weekly with the ability to dose 45-60 IU/kg every five days and then individually adjust to less or more frequent dosing based on bleeding episodes. Dosing of the intravenous infusible for on-demand treatment is based on the degree of bleeding, and dosing for perioperative management is based on the type of surgery. Visit www.jivi.com.

✦✦Aug. 31: The FDA approved Merck’s Delstrigo (doravirine/lamivudine/tenofovir disoprox-il fumarate) for the treatment of HIV-1 infection in adults with no prior antiretroviral treatment. It is a once-daily, fixed-dose combination tablet, and it’s priced at $70 per day, or $25,550 per year. The company says it expects the drug to be avail-able within one month. Visit www.delstrigo.com.

✦✦Aug. 31: The FDA approved Mer-ck’s Pifeltro (doravirine) in com-bination with other antiretroviral agents for the treatment of HIV-1 infection in adults with no prior antiretroviral treatment. The recom-mended dose of the non-nucleoside reverse transcriptase inhibitor is one 100 mg tablet daily. Its price is $46 per day, or $16,790 per year. The company says it expects the drug to be available within one month. Visit www.pifeltro.com.

New FDA Specialty Approvals (continued)


Follow Radar on Specialty Pharmacy at: twitter.com/AISHealth • linkedin.com/company/62243

NPF Excludes Rare Disease Drugs continued from p. 82017 with a wholesale acquisition cost (WAC) list price for a one-month supply that was more than 50% lower than the list price of other therapies.” Citing Pharmaceutical Technology, Fein said that the list price for an eight-week course of Mavyret is $26,400, and a 12-week course is $39,600. That’s compared with the 12-week Harvoni list price of $94,500 and Epclusa’s $74,760. “Rebates can be substantial, so the list prices do not meaningfully reflect the net cost to a payer,” he noted.

“Express Scripts has excluded Mavyret, the lowest list price product that can treat the one in four patients who has HCV [i.e., hepatitis C virus] genotype 2 and 3,” he said. “These pa-tients can’t take Zepatier, which treats only genotypes 1 and 4. They will therefore most likely be treated with Harvoni, a product with a higher list price and presumably high rebates.”

With discounts reflected in average sales price, this “translates into savings for a payer compared with paying from WAC,” notes Schafer.

Fein also pointed out that “pa-tients with commercial insurance often have prescription drug deductibles and coinsurance, so their out-of-pock-et costs are linked to undiscounted, pre-rebate list prices. Patients with HCV genotypes 2, 3, 5, and 6 will face higher costs due to these formulary exclusions. They won’t benefit from a low net price. If physicians end up prescribing Harvoni or Epclusa over Zepatier, then patients with genotypes 1 and 4 will also get stuck with higher out-of-pocket costs tied to the higher list prices.”

When Fein queried Express Scripts about patients’ higher out-of-pocket

costs due to Mavyret’s exclusion, he said a spokesperson told him that “the copay card would be an option.”

Luddy tells AIS Health that those members on the excluded factor VIII, HIV and hepatitis C excluded drugs “will be grandfathered per guidance from our internal clinical team and our independent pharmacy & therapeutics committee.” However, this doesn’t ap-ply to all the excluded drugs but rather only “for those where it is clinically necessary.” The PBM also will grandfa-ther “a few others” outside these three therapeutic classes.

View the exclusions at https://tinyurl.com/y78jy5kf. View Fein’s blog at https://tinyurl.com/y89wr82l. Con-tact Schafer through Tess Rollano at [email protected]. G

Senate introduced a similar bill shortly thereafter. The Medicare Home Infu-sion Therapy Access Act of 2017 finally was enacted earlier this year when President Trump signed the Bipartisan Budget Act of 2018 on Feb. 9. The act establishes a transitional payment that kicks in Jan. 1, 2019.

However, a proposed rule issued this summer, titled Medicare and Med-icaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; Home Infusion Therapy Requirements; and Training Requirements for Surveyors of National Accrediting Organizations (83 Fed. Reg. 32340, July 12, 2018) is threatening to undo much of what that other legislation established.

Comment Period Ended Recently

The comment period on that proposed rule ended Aug. 31. NHIA spokesperson Marilyn Tretler notes that CMS typically will finalize rules 60 days after the comment period closes, so by that approach, CMS will issue the final rule on or around Nov. 1. That said, “It’s a bit of a moving target. They can choose to move forward with one part and not the other.” But it needs to be implemented by Jan. 1 for the transitional payments to kick in.

NHIA shared its comment letter with AIS Health in response to ques-tions about the proposal and potential ramifications were it to be implement-ed as is. The association, as well as some members of Congress, takes issue with two provisions of the proposed rule: the physical presence requirement and the definition of professional ser-vices required for home infusion.

In describing the “infusion drug administration calendar day,” the pro-

Groups Call for Language Changescontinued from p. 1

The Cures Act, however, changed the reimbursement methodology for these drugs to ASP as of Jan. 1, 2017. So rather than being reimbursed at AWP -5%, these drugs are now paid at the ASP +6% rate used for most Part B drugs. About 30 drugs have been affected by the shift to ASP, and while the impact hasn’t been negative for all of those therapies, two drugs in particular are taking the biggest hits. Reimbursement for inotropic agent milrinone dropped about 92%, and subcutaneous immune globulin (IG) Hizentra dropped about 31%. Other subcutaneous IG products such as Ga-munex and Gammagard have suffered hits between 21% and 31%.

In 2017, members of Congress in-troduced legislation to plug the gap be-tween the ASP reimbursement change that went into effect Jan. 1, 2017, and the professional services reimbursement that goes into effect Jan. 1, 2021. The House passed it July 25, 2017, and the



for the beneficiary’s home infusion. To remain true to both the legislation and our intent, CMS should withdraw the requirement that a nurse or other professional be physically present ‘in the home’ for reimbursement to occur, and instead to recognize that reim-bursement be made for each day that a home infusion drug is infused.”

Goal of Bill Was Patient Freedom

The goal of the bill, they say, “was to give patients freedom to receive these infusions in the comfort of their own home, without having to make the sometimes onerous journey to a healthcare facility to receive an infu-sion. Congress intended to give free-dom to the patients in this legislation, allowing them to administer their own infusions at home without a healthcare worker.”

Another benefit to patients — many of whom have compromised immune systems — of receiving infu-sions in their home is this location is safer health-wise in that they aren’t at risk of getting a health care-associated infection from a site of care such as a hospital outpatient department.

In addition, Isakson and Warner note that their “intent was that home infusion providers’ professional ser-vices, such a drug preparation, clinical care planning, care coordination, nurs-ing and other associated professional work should be a component of the home infusion benefit.…The legisla-tion is clear that the ‘nursing services’ are a subset of ‘professional services,’ and we made reference to nursing ser-vices to clarify that they were not to be separately billable from the other pro-fessional services.” The senators urge CMS to come up with “a definition of professional services that is unique to home infusion.” They also clarify that

the services are not covered under the DME benefit.

Through the proposed rule, says Rep. Earl “Buddy” Carter (R-Ga.) — who is the lone pharmacist in Congress — “CMS has virtually eliminated any reference to pharmacy services as pro-fessional services for reimbursement. It is vital that professional services in-clude drug preparation and dispensing. The drugs that home infusion suppliers provide to patients require extensive pharmacy services, including the com-pounding of the drugs. By ignoring pharmacy services as a professional ser-vice CMS has created a home infusion benefit that incorrectly focuses solely on nursing services,” he says in a letter commenting on the proposed rule.

Rule Impacts Permanent Payment Also

According to NHIA, “For the permanent payment, the proposed rule would adopt the same definition to limit the payment in the same way. By tying this definition to face-to-face nursing services, this definition would exclude coverage and reimbursement for the myriad of other professional services needed for safe and effective delivery of home infusion therapy, including sterile compounding, clinical care planning, care coordination, nurs-ing and other associated professional services.” This means that through the proposed rule, both temporary and permanent reimbursement would be limited “to only a small subset of the many professional services furnished in connection with home infusion ther-apy.”

NHIA maintains that the lim-itation of reimbursement is “inap-propriate for two reasons. First, this limitation is contrary to the text and structure of the statutes directing CMS to reimburse home infusion therapy services. Second, providing for pay-

posed regulation explains that it under-stands the act to mean that “payment is only for the day on which the nurse is in the patient's home when an infusion drug is being administered.…Payment is made only for the day on which the administration of the infusion drug occurs even if professional services were furnished on a different day. Therefore, we propose to define in regulation that payment for an infusion drug admin-istration calendar day is for the day on which home infusion therapy services are furnished by skilled professional(s) in the individual's home on the day of infusion drug administration. The skilled services provided on such day must be so inherently complex that they can only be safely and effectively performed by, or under the supervision of, professional or technical personnel.”

Physical Presence Contradicts Intent

In a letter commenting on the proposed rule, Sens. Johnny Isakson (R-Ga.) and Mark Warner (D-Va.) — authors of the Medicare Home Infusion Therapy Access Act of 2017 — state that in their legislation, the benefit was intended to cover “pro-fessional services, including nursing services.” But the physical presence required in the proposed rule “con-tradicts our intent in drafting and enacting this legislation and makes the reimbursement required by the bill inadequate.”

According to Isakson and War-ner, “In preparing this legislation, we worked to mirror this benefit as closely as possible to private sector and other governmental home infusion programs. No other payers for home infusion (commercial plans, Medi-care Advantage Plans, the Veterans Administration, or others) have such a requirement for a professional to be physically present in order to reimburse



ment only on a day on which nursing services are furnished fails to take into account the many professional services that are necessary to deliver home infu-sion therapy to the patient, and would therefore make it impractical for home infusion therapy suppliers to continue to provide these services.”

NHIA explains that home infusion pharmacists prepare and compound drugs, assess the possibility of med-ication interactions and coordinate with care teams, as opposed to nursing services, which almost always are face-to-face encounters with patients. With the proposed rule specifically refer-encing a face-to-face interaction, this “would treat the home infusion therapy pharmacy components of professional services reimbursement as a nursing benefit and would assume away the crucial additional professional services necessary to deliver home infusion therapy.” This, says the association,

“would fail to implement Congress’s instruction.”

NHIA also points out that the proposed rule equates “a day the drug is administered” with its proposed defi-nition of infusion drug administration calendar day, a day when a nurse is in the home of the patient. This is prob-lematic because a nurse is not present for every infusion of a drug. “Depend-ing on the specific circumstances, a patient may only need a single visit per week in connection with drugs that can be self-infused or infused by the pa-tient’s caregiver on each of the remain-ing six days,” says NHIA. “In failing to take such an arrangement into account, in effect, the proposed rule would de-mand that a supplier accept one day of payment for one week of professional services.”

In a letter responding to the proposed rule, Rep. Pete Sessions (R-Texas) notes another problem. The Congressional Budget Office estimated

that the home infusion benefit as part of the budget act would cut down on federal costs and boost the number of home infusion days to 25 million infusions for each of the two transi-tional years. “This estimate is in direct conflict with the CMS projections of payment once a week or once a month resulting in 305,000 total visits of care” in 2019, as indicated in the proposed rule.

The upshot?

“The proposed rule, ironically, would cost the Medicare program significantly more money by shifting Medicare beneficiaries unable to access infusion in the home into far costlier inpatient settings and skilled nursing facilities.”

View NHIA’s resources page for the transitional reimbursement law, which includes links to the congres-sional letters, at https://tinyurl.com/y6v9g4w9. Contact Tretler at [email protected]. G

News Briefs

✦✦A group of industry stakeholders, including insurers, hospitals, phar-macists, CVS Health and Prime Therapeutics LLC, recently sent a letter to FDA Commissioner Scott Gottlieb, M.D., calling for the FDA to finalize the draft interchange-able biosimilars guidance — which it issued in January 2017 (RSP 2/17, p. 4) — in order to increase com-petition within the pharmaceutical marketplace. Interchangeable desig-nation would allow pharmacists in states that allow therapeutic substi-tution to automatically substitute an interchangeable biosimilar for its reference product without interven-tion from the health care provider who prescribed the reference prod-

uct. While the FDA has approved 12 biosimilars, it has not granted inter-changeable status to any of them. View the letter at https://tinyurl.com/y85qebqh.

✦✦Pfizer Inc. filed a citizen petition last month asking the FDA’s Got-tlieb to “issue guidance clarifying appropriate sponsor communica-tions about the nature and proper-ties of biosimilar products.” It cites specific companies and their com-munications that it says are false and misleading. The company maintains that part of the reason behind the slow uptake of biosimilars is “a lack of market confidence in biosimilars resulting from the efforts of certain

reference product sponsors to dis-seminate false and misleading infor-mation that casts doubt about the safety and efficacy of biosimilars in the minds of patients and prescrib-ers.” View the petition at https://tinyurl.com/ybtcy8lp.

✦✦PEOPLE ON THE MOVE: Village Fertility Pharmacy named Richard J. Burkett CEO. He previously was U.S. head of sales, marketing, and strategic partnerships within EMD Serono Inc.’s U.S. fertility business. Village also named Michael Abramo chief financial officer. He was the chief administrator of the Massachu-setts Bay Transportation Authority most recently.


Documents

Specialty Pharmacy - National Home Infusion Association · 2020. 4. 21. · ment System. Multiple benefits to using indi-cation-based formularies exist. Plan sponsors will have the